# K053404: Lifestent Flexstart Biliary Stent System

- Pathway: 510(k) (Special)
- Applicant: Edwards Lifesciences, LLC
- Decided: Dec 21, 2005 after 14 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: 103 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K010445 (2001). 8 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024303: Edwards Lifesciences Lifestent NT18 Self-Expanding Biliary Stent and Delivery System, Edwards Lifesciences, LLC (2003) Summary page 1.
- K042985: Lifestent NT35 Biliary Stent System, Edwards Lifesciences, LLC (2004) Summary page 1.

## Most influential descendants
- K060487: Lifestent Flexstar XL Biliary Stent System (2006), 1 descendant of its own
- K130792: Lifestent Biliary Stent System, Lifestent XL Biliary Stent System (2013), 0 descendants of its own

## Recalls of this device
- Aug 29, 2008 · Not classified · Z-0043-2009: Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible.
- Aug 29, 2008 · Not classified · Z-0064-2009: Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible.
- Aug 29, 2008 · Not classified · Z-0071-2009: Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible.
- Aug 29, 2008 · Not classified · Z-0066-2009: Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible.
- Aug 29, 2008 · Not classified · Z-0037-2009: Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible.
- Aug 29, 2008 · Not classified · Z-0058-2009: Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible.
- Aug 29, 2008 · Not classified · Z-0082-2009: Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible.
- Aug 29, 2008 · Not classified · Z-0077-2009: Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible.
- Aug 29, 2008 · Not classified · Z-0075-2009: Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible.
- Aug 29, 2008 · Not classified · Z-0038-2009: Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible.
- Aug 29, 2008 · Not classified · Z-0059-2009: Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible.
- Aug 29, 2008 · Not classified · Z-0048-2009: Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible.
- Aug 29, 2008 · Not classified · Z-0049-2009: Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible.
- Aug 29, 2008 · Not classified · Z-0070-2009: Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible.
- Aug 29, 2008 · Not classified · Z-0072-2009: Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible.
- Aug 29, 2008 · Not classified · Z-0054-2009: Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible.
- Aug 29, 2008 · Not classified · Z-0063-2009: Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible.
- Aug 29, 2008 · Not classified · Z-0085-2009: Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible.
- Aug 29, 2008 · Not classified · Z-0055-2009: Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible.
- Aug 29, 2008 · Not classified · Z-0073-2009: Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible.
- Aug 29, 2008 · Not classified · Z-0081-2009: Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible.
- Aug 29, 2008 · Not classified · Z-0083-2009: Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible.
- Aug 29, 2008 · Not classified · Z-0056-2009: Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible.
- Aug 29, 2008 · Not classified · Z-0046-2009: Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible.
- Aug 29, 2008 · Not classified · Z-0040-2009: Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible.
- Aug 29, 2008 · Not classified · Z-0057-2009: Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible.
- Aug 29, 2008 · Not classified · Z-0050-2009: Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible.
- Aug 29, 2008 · Not classified · Z-0047-2009: Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible.
- Aug 29, 2008 · Not classified · Z-0060-2009: Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible.
- Aug 29, 2008 · Not classified · Z-0068-2009: Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible.
- Aug 29, 2008 · Not classified · Z-0035-2009: Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible.
- Aug 29, 2008 · Not classified · Z-0051-2009: Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible.
- Aug 29, 2008 · Not classified · Z-0042-2009: Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible.
- Aug 29, 2008 · Not classified · Z-0045-2009: Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible.
- Aug 29, 2008 · Not classified · Z-0052-2009: Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible.
- Aug 29, 2008 · Not classified · Z-0061-2009: Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible.
- Aug 29, 2008 · Not classified · Z-0080-2009: Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible.
- Aug 29, 2008 · Not classified · Z-0074-2009: Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible.
- Aug 29, 2008 · Not classified · Z-0084-2009: Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible.
- Aug 29, 2008 · Not classified · Z-0067-2009: Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible.
- Aug 29, 2008 · Not classified · Z-0062-2009: Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible.
- Aug 29, 2008 · Not classified · Z-0039-2009: Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible.
- Aug 29, 2008 · Not classified · Z-0069-2009: Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible.
- Aug 29, 2008 · Not classified · Z-0076-2009: Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible.
- Aug 29, 2008 · Not classified · Z-0079-2009: Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible.
- Aug 29, 2008 · Not classified · Z-0036-2009: Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible.
- Aug 29, 2008 · Not classified · Z-0041-2009: Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible.
- Aug 29, 2008 · Not classified · Z-0065-2009: Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible.
- Aug 29, 2008 · Not classified · Z-0044-2009: Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible.
- Aug 29, 2008 · Not classified · Z-0053-2009: Some LifeStent FlexStar Systems may exhibit a gap between the tip of the delivery system and the primary sheath such that the guidewire lumen is visible.

## Indications for use
The Edwards Lifesciences LifeStent FlexStar Biliary Stent System is indicated for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

Source page: https://510kreport.com/device/K053404
Methodology: https://510kreport.com/methodology